drugset
drugset / Trial / NCT06307093

Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms

NCT06307093 ↗

Phase 1 Completed 90 enrolled R-Pharm Data Management 365 · collabExacte Labs LLC · collabFederal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation · collabFederal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen. The main main tasks are: * To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms; * To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen. This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy.

Timeline

Start
2023-03-01
Primary completion
2023-07-15
Completion
2025-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications

cutaneous melanoma head and neck squamous cell carcinoma non-small cell squamous lung carcinoma